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Dense Gas Particle Processing for Alternative Drug Delivery Formulations

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Dense Gas Particle Processing for Alternative Drug Delivery Formulations Dense Gas Particle Processing For Alternative Drug Delivery Formulations by Andrian Tandya, B. E. (Chemical Engineering) A Thesis Submitted to the School of Chemical Sciences and Engineering in Partial Fulfillment of the equirements for the Degree of Doctor of Philosophy The University of New South Wales Sydney, Australia September 2006 PLEASE TYPE THE UNIVERSITY OF NEW SOUTH WALES Thesis/Dissertation Sheet Surname or Family name: TANDYA First name: ANDRIAN Other name/s: Abbreviation for degree as given in the University calendar: School: Chemical Sciences and Engineering Faculty: Engineering Title: Dense Gas Particle Processing For Alternative Drug Delivery Formulations Abstract 350 words maximum: (PLEASE TYPE) Pulmonary and oral drug administrations are usually the preferred methods of delivery of active pharmaceutical ingredients. Generally, pulmonary drug formulations are more attractive compared to oral formulations since they consist of micron-sized powders with high surface area thus having faster onset of action, as well as minimizing the drug dosage and side effects. Oral insulin formulations, if achievable, would provide an alternative to injectable insulin, as the common drawbacks of injectable insulin are the multiple daily injections and the possibility of skin infections at the injection site. n this study, the feasibility of using dense gas particle processing techniques known as the Aerosol Solvent Extraction System (ASES), Gas Anti-Solvent (GAS) and (igh-Pressure Media Milling ((PMM) for pharmaceutical processing was assessed. The ASES technique, utilizing dense ethane, was employed to prepare insulin-lactose formulations for pulmonary administration whilst the GAS and ASES techniques, utilizing dense CO2, were employed to prepare microencapsulated formulations containing insulin and Eudragit- S.00 for oral administration. 0urthermore, the (PMM technique, utilizing dense hydrofluocarbon ((0C) .12a3227ea, was employed to prepare suspension Metered 5ose nhaler (M5 ) formulations containing budesonide and various surfactants. The 0ine Particle 0raction (0P0) of processed insulin without the presence of lactose was found to be 226. n other words, 226 of processed insulin delivered to the impactor stages (excluding the throat and neck) has aerodynamic diameter of less than 7 µm. 8ith the addition of lactose as carrier, the 0P0 of the insulin-lactose (.9. w3w) formulation increased to 626. The increase in 0P0 was attributed to the lower density of lactose particles compared to that of insulin particles to produce an intimate mixture with enhanced powder flowability and aerodynamic performance. Proteins for oral delivery should ideally be formulated with acid-resistant polymer as a protective coating to protect against enzymatic degradation in the stomach. Eudragit- S.00, which is insoluble or almost impermeable at p( .-2 and soluble at p( 7-7, was used to prepare oral insulin formulations. The insulin release at p( 1 was sustained by the Eudragit- S.00 coating and the encapsulation efficiency of insulin;Eudragit- S.00 formulations varied between 66 and 226 depending on the initial drug to polymer ratio. One of the major therapies utilizing metered dose inhaler formulations in the treatment of asthma has been studied using the (PMM process. The (PMM process has been demonstrated to be an efficient milling process for the enhancement of the physical stability and aerodynamic performance of budesonide in (0C-.12a3227ea propellant formulations. No significant change in physical stability was observed in the formulations for 2 weeks. Declaration relating to disposition of project thesis/dissertation I hereby grant to the University of New South Wales or its agents the right to archive and to make available my thesis or dissertation in whole or in part in the University libraries in all forms of media, now or here after known, subject to the provisions of the Copyright Act 1968. I retain all property rights, such as patent rights. I also retain the right to use in future works (such as articles or books) all or part of this thesis or dissertation. I also authorise University Microfilms to use the 350 word abstract of my thesis in Dissertation Abstracts International (this is applicable to doctoral theses only). …………………………………………………………… ……………………………………..……………… ……….……………………...…….… Signature Witness Date The University recognises that there may be exceptional circumstances requiring restrictions on copying or conditions on use. Requests for restriction for a period of up to 2 years must be made in writing to the Registrar. Requests for a longer period of restriction may be considered in exceptional circumstances if accompanied by a letter of support from the Supervisor or Head of School. Such requests must be submitted with the thesis/dissertation. FOR OFFICE USE ONLY Date of completion of requirements for Award: Registrar and Deputy Principal THIS SHEET IS TO BE GLUED TO THE INSIDE FRONT COVER OF THE THESIS N:\FLORENCE\ABSTRACT Abstract Pulmonary and oral drug administrations are usually the preferred methods of delivery of active pharmaceutical ingredients. (enerally, pulmonary drug formulations are more attractive compared to oral formulations since they consist of micron-sized powders with high surface area thus having faster onset of action, as well as minimizing the drug dosage and side effects. ,ral insulin formulations, if achievable, would provide an alternative to in-ectable insulin, as the common drawbac.s of in-ectable insulin are the multiple daily in-ections and the possibility of s.in infections at the in-ection site. In this study, the feasibility of using dense gas particle processing techniques .nown as the Aerosol Solvent E0traction System (ASES), (as Anti-Solvent ((AS) and 1igh-Pressure 2edia 2illing (1P22) for pharmaceutical processing was assessed. The ASES technique, utilizing dense ethane, was employed to prepare insulin-lactose formulations for pulmonary administration whilst the (AS and ASES techniques, utilizing dense C,2, were employed to prepare microencapsulated formulations containing insulin and Eudragit3 S100 for oral administration. Furthermore, the 1P22 technique, utilizing dense hydrofluocarbon (1FC) 134a7228ea, was employed to prepare suspension 2etered Dose Inhaler (2DI) formulations containing budesonide and various surfactants. The Fine Particle Fraction (FPF) of processed insulin without the presence of lactose was found to be 449. In other words, 449 of processed insulin delivered to the impactor stages (e0cluding the throat and nec.) has aerodynamic diameter of less than 5 µm. With the addition of lactose as carrier, the FPF of the insulin-lactose (1:1 w7w) formulation increased to 649. The increase in FPF was attributed to the lower density of lactose particles compared to that of insulin particles to produce an intimate mi0ture with enhanced powder flowability and aerodynamic performance. Proteins for oral delivery should ideally be formulated with acid-resistant polymer as a protective coating to protect against enzymatic degradation in the stomach. ii Eudragit3 S100, which is insoluble or almost impermeable at p1 1-4 and soluble at p1 5-8, was used to prepare oral insulin formulations. The insulin release at p1 3 was sustained by the Eudragit3 S100 coating and the encapsulation efficiency of insulin=Eudragit3 S100 formulations varied between 69 and 249 depending on the initial drug to polymer ratio. ,ne of the ma-or therapies utilizing metered dose inhaler formulations in the treatment of asthma has been studied using the 1P22 process. The 1P22 process has been demonstrated to be an efficient milling process for the enhancement of the physical stability and aerodynamic performance of budesonide in 1FC-134a7228ea propellant formulations. No significant change in physical stability was observed in the formulations for 2 wee.s. iii Ac.nowledgments I would li.e to e0press my gratitude to my supervisor Prof. Neil . Foster for his advice, guidance and role in the development of myself as a researcher and as a person throughout this doctoral degree. I would also li.e to than. Neil for all his thoughtful and beneficial feedbac. for my thesis. 2y special than.s to Dr. Fariba Dehghani, Dr. affaella 2ammucari and Dr. Louise 2eure who have provided invaluable assistance throughout the period of research. Their encouragement, invaluable technical advice and proof reading tas. for my thesis are very much appreciated. I would also li.e to than. Dr. Keith 1utchenson and Dr. Eri. (ommeren from DuPont esearch and Development, ASA. Their willingness to share their research .nowledge and e0perience is something I will always appreciate and value. 2y gratitude is e0tended for Dr. Emma Coen, Dr. Linda Sze Tu, Peter Baltchev and Angela Barrett for their continuous friendship and support. I personally e0tend my gratitude to Aaron Ng and oderic. Sih for their personal input and support to ma.e my life, both inside and outside the Aniversity, so much better. Lastly, but definitely not least, I would li.e to ta.e this opportunity to e0press my deepest gratitude to Lince udy for her love, constant support and tireless encouragement throughout my research especially during the most difficult situation. This volume of wor. would not have been possible without her support, and therefore I would li.e to dedicate this thesis to her. iv Dedicated to Lince Rudy v Table of Contents . INTRODUCTION.................................................................................. 2. FUNDAMENTALS AND APPLICATIONS
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